WO2025008417A1

WO2025008417A1 - Negative pressure wound therapy devices and methods

Info

Publication number: WO2025008417A1
Application number: PCT/EP2024/068767
Authority: WO
Inventors: Varuni Rachindra BROWNHILL; Edward Yerbury Hartwell; Peter Georg Laitenberger; Alfred Charles Percey MUNRO; Luke Michael PARRY; Neill John RAWSON; Iain James Sabberton; Iain Webster
Original assignee: TJ Smith and Nephew Ltd
Current assignee: TJ Smith and Nephew Ltd
Priority date: 2023-07-05
Filing date: 2024-07-03
Publication date: 2025-01-09
Anticipated expiration: 2026-01-05
Also published as: AU2024290716A1; GB202310268D0

Abstract

A negative pressure wound treatment system and methods for using such a system are described. Preferred embodiments facilitate closure of the wound by preferentially contracting to provide for movement of the tissue. Some embodiments may include a wound filler conglomerate having filler material and a wound contact layer.

Description

NEGATIVE PRESSURE WOUND THERAPY DEVICES AND METHODS

BACKGROUND

Technical Field

[0001] Embodiments described herein relate to apparatuses, systems, and methods for the treatment of wounds, for example using dressings in combination with negative pressure wound therapy.

Description of the Related Art

[0002] Many different types of wound dressings are known for aiding in the healing process of a human or animal. These different types of wound dressings include many different types of materials and layers, for example, gauze, pads, foam pads or multilayer wound dressings. Topical negative pressure (TNP) therapy, sometimes referred to as vacuum assisted closure, negative pressure wound therapy, or reduced pressure wound therapy, is widely recognized as a beneficial mechanism for improving the healing rate of a wound. Such therapy is applicable to a broad range of wounds such as incisional wounds, open wounds, and abdominal wounds or the like. TNP therapy assists in the closure and healing of wounds by reducing tissue edema, encouraging blood flow, stimulating the formation of granulation tissue, removing excess exudates and may reduce bacterial load. Thus, reducing infection to the wound. Furthermore, TNP therapy permits less outside disturbance of the wound and promotes more rapid healing

[0003] Existing negative pressure therapy wound fillers, such as foam or gauze, may shed fibers or particulates into a wound, which can cause inflammation, redness, irritation, infection, and/or increased wound treatment time. Further, removal of foam or gauze wound filler materials may cause pain to a patient and may inadvertently cause removal of healthy granulated tissue from the wound.

[0004] Further, because wounds are of different shapes and/or sizes, foam, gauze, or other wound fillers may need to be sized, shaped, layered, or otherwise prepared to better accommodate wounds. Although existing foam, gauze, or other wound fillers may be cut to certain size or shape, the adjustment may require time. Additionally, a wound may change in size or shape as negative pressure treatment is applied to the wound. [0005] Accordingly, there is a need to provide for an improved apparatus, method, and system for the treatment and closure of wounds.

SUMMARY

[0006] Embodiments of the present disclosure relate to materials, devices, methods, and systems for wound treatment. Some disclosed embodiments relate to materials, devices, methods, and systems for delivering negative pressure to a wound. It will be understood by one of skill in the art that application of the materials, devices, methods, and systems described herein are not limited to a particular tissue or a particular injury.

[0007] In some examples, a wound therapy device may comprise a plurality of modules configured to contact a wound, individual modules comprising a porous wound filler and a wound contact layer, the wound contact layer enclosing the wound filler. The wound filler and the wound contact layer may comprise different materials. The wound filler material may comprise foam and the wound contact layer may comprise perforations. In certain examples, the wound contact layer may comprise silicone. The wound contact layer may comprise polyurethane. The wound contact layer may be substantially transparent. In some examples, the modules may be removably connected to one other. Adjacent individual modules may be removably connected to each other by a connection component. The connection component and the contact layer are may be monolithic. The connection component may comprise cord. The connection component may comprise a string and/or a synthetic polymer. In certain examples, the connection component may comprise a plurality of collagen threads. In some examples, the wound therapy device may include a connection configured to supply a source of negative pressure to a space beneath the wound contact layer.

[0008] In certain examples, a method of treating a wound may comprise applying a wound therapy device to a wound, the wound therapy device comprising a plurality of modules, individual modules comprising a wound filler enclosed by a wound contact layer, the wound filler comprising a first material and the wound contact layer comprising a second material, and applying negative pressure to a space beneath the wound contact layer. In some examples, the method may involve applying the wound therapy device to the wound in a layered configuration. The method may involve applying the wound therapy device to the wound in a rolled configuration. The method may involve applying the wound therapy device to the wound in a loose and/or folded configuration.

[0009] Disclosed herein are methods of operating a negative pressure wound therapy device of any of the preceding paragraphs and/or any of the devices, apparatuses, or systems disclosed herein.

[0010] Disclosed herein are kits that include the negative pressure wound therapy device of any of the preceding paragraphs and/or any of the devices, apparatuses, or systems disclosed herein and one or more wound dressings.

[0011] Any of the features, components, or details of any of the arrangements or embodiments disclosed in this application, including without limitation any of the apparatus embodiments and any of the negative pressure wound therapy embodiments disclosed herein, are interchangeably combinable with any other features, components, or details of any of the arrangements or embodiments disclosed herein to form new arrangements and embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1A illustrates an example of negative pressure wound therapy system.

[0013] Figure IB illustrates another example of a negative pressure wound therapy system.

[0014] Figure 2 illustrates a top view of an example of a wound filler conglomerate.

[0015] Figure 3 illustrates a top view of an example of a wound contact layer.

[0016] Figure 4 illustrates an example of a wound filler conglomerate applied to a wound.

[0017] Figure 5 illustrates an example of a wound filler conglomerate applied to a wound.

[0018] Figure 6 illustrates an example of a modular wound filler conglomerate.

[0019] Figure 7A illustrates an example of a modular wound filler conglomerate.

[0020] Figure 7B illustrates another view of the modular wound filler conglomerate shown in Figure 7A. [0021] Figure 7C illustrates another view of the modular wound filler conglomerate shown in Figure 7A.

[0022] Figure 8 A illustrates an example of a wound filler conglomerate.

[0023] Figure 8B illustrates another view of the wound filler conglomerate shown in Figure 8 A.

[0024] Figure 9 illustrates an example of a wound filler conglomerate applied in a free configuration to a wound.

[0025] Figure 10 illustrates an example of a wound filler conglomerate applied in a layered configuration to a wound.

[0026] Figure 11 illustrates an example of a wound filler conglomerate applied in a layered configuration to a wound.

[0027] Figure 12 illustrates an example of a wound filler conglomerate applied in a rolled configuration to a wound.

[0028] Figure 13 illustrates an example of a wound filler conglomerate applied in a spiraled configuration to a wound.

[0029] Figure 14 illustrates an example of a wound filler conglomerate applied in a gathered configuration to a wound.

[0030] Figure 15 illustrates an example of a wound filler conglomerate applied in a folded configuration to a wound.

[0031] Figure 16A illustrates an example of a wound filler conglomerate.

[0032] Figure 16B illustrates an example of a wound filler conglomerate.

DETAILED DESCRIPTION

[0033] Embodiments disclosed herein relate to systems and methods of treating and/or monitoring a wound. Some embodiments of the negative pressure wound therapy devices disclosed herein can include a negative pressure source configured to be connected and/or fluidically coupled, via a fluid flow path, to a wound covered by a wound dressing and provide negative pressure to a wound.

[0034] Throughout this specification reference is made to a wound. The term wound is to be broadly construed and encompasses open and closed wounds in which skin is torn, cut or punctured or where trauma causes a contusion, or any other superficial or other conditions or imperfections on the skin of a patient or otherwise that benefit from pressure treatment. A wound is thus broadly defined as any damaged region of tissue where fluid may or may not be produced. Examples of such wounds include, but are not limited to, abdominal wounds or other large or incisional wounds, either as a result of surgery, trauma, sterniotomies, fasciotomies, or other conditions, dehisced wounds, acute wounds, chronic wounds, subacute and dehisced wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, bums, diabetic ulcers, pressure ulcers, stoma, surgical wounds, trauma and venous ulcers or the like.

[0035] Embodiments of systems and methods disclosed herein can be used with topical negative pressure (“TNP”) or reduced pressure therapy systems. Briefly, negative pressure wound therapy assists in the closure and healing of many forms of “hard to heal” wounds by reducing tissue oedema, encouraging blood flow and granular tissue formation, or removing excess exudate and can reduce bacterial load (and thus infection risk). In addition, the therapy allows for less disturbance of a wound leading to more rapid healing. TNP therapy systems can also assist in the healing of surgically closed wounds by removing fluid. TNP therapy can help to stabilize the tissue in the apposed position of closure. A further beneficial use of TNP therapy can be found in grafts and flaps where removal of excess fluid is important and close proximity of the graft to tissue is required in order to ensure tissue viability.

[0036] As used herein, reduced or negative pressure levels, such as -X mmHg, represent pressure levels relative to normal ambient atmospheric pressure, which can correspond to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Accordingly, a negative pressure value of -X mmHg reflects pressure that is X mmHg below 760 mmHg or, in other words, a pressure of (760-X) mmHg. In addition, negative pressure that is “less” or “smaller” than X mmHg corresponds to pressure that is closer to atmospheric pressure (for example, -40 mmHg is less than -60 mmHg). Negative pressure that is “more” or “greater” than -X mmHg corresponds to pressure that is further from atmospheric pressure (for example, -80 mmHg is more than -60 mmHg). In some cases, local ambient atmospheric pressure is used as a reference point, and such local atmospheric pressure may not necessarily be, for example, 760 mmHg. [0037] Systems and methods disclosed herein can be used with other types of treatment in addition to or instead of reduced pressure therapy, such as irrigation, ultrasound, heat or cold, neuro stimulation, or the like. In some cases, disclosed systems and methods can be used for wound monitoring without application of additional therapy. Systems and methods disclosed herein can be used in conjunction with a dressing, including with compression dressing, reduced pressure dressing, or the like.

[0038] A healthcare provider, such as a clinician, nurse, or the like, can provide a TNP prescription specifying, for example, the pressure level or time of application. However, the healing process is different for each patient and the prescription may affect the healing process in a way the clinician or healthcare provider did not expect at the time of devising the prescription. A healthcare provider may try to adjust the prescription as the wound heals (or does not heal), but such process may require various appointments that can be time consuming and repetitive. Embodiments disclosed herein provide systems, devices, or methods of efficiently adjusting TNP prescriptions and delivering effective TNP therapy.

Wound Therapy System

[0039] Figure 1A schematically illustrates a negative pressure wound treatment system 100’ (sometimes referred to as a reduced or negative pressure wound therapy system, a TNP system, or a wound treatment system). In any implementations disclosed herein, though not required, the negative pressure wound treatment system 100’ can include a wound filler 102 placed on or inside a wound 104 (which may be a cavity). The wound 104 can be sealed by a wound cover 106, which can be a drape, such that the wound cover 106 can be in fluidic communication with the wound 104. The wound filler 102 in combination with the wound cover 106 can be referred to as a wound dressing. A tube or conduit 108’ (also referred to herein as a flexible suction adapter or a fluidic connector) can be used to connect the wound cover 106 with a wound therapy device 110’ (sometimes as a whole or partially referred to as a “pump assembly”) configured to supply reduced or negative pressure. The conduit 108’ can be a single or multi lumen tube. A connector can be used to removably and selectively couple a conduit or tube of the device 110’ with the conduit 108’.

[0040] In any of the systems disclosed herein, a wound therapy device can be canisterless, wherein, for example and without limitation, wound exudate is collected in the wound dressing or is transferred via a conduit for collection at another location. However, any of the wound therapy devices disclosed herein can include or support a canister.

[0041] Additionally, with any of the wound therapy systems disclosed herein, any of the wound therapy devices can be mounted to or supported by the wound dressing or adjacent to the wound dressing. The wound filler 102 can be any suitable type, such as hydrophilic or hydrophobic foam, gauze, inflatable bag, and so on. The wound filler 102 can be conformable to the wound 104 such that the wound filler 102 substantially fills the cavity of the wound 104. The wound cover 106 can provide a substantially fluid impermeable seal over the wound 104. The wound cover 106 can have a top side and a bottom side. The bottom side can adhesively (or in any other suitable manner) seal with the wound 104, for example by sealing with the skin around the wound 104. The conduit 108 or any other conduit disclosed herein can be formed from polyurethane, PVC, nylon, polyethylene, silicone, or any other suitable material.

[0042] The wound cover 106 can have a port (not shown) configured to receive an end of the conduit 108. In some cases, the conduit 108 can otherwise pass through or under the wound cover 106 to supply reduced pressure to the wound 104 so as to maintain a desired level of reduced pressure in the wound 104. The conduit 108 can be any suitable article configured to provide at least a substantially sealed fluid flow pathway or path between the wound therapy device 110’ and the wound cover 106, so as to supply the reduced pressure provided by the wound therapy device 110’ to wound 104.

[0043] The wound cover 106 and the wound filler 102 can be provided as a single article or an integrated single unit. In some cases, no wound filler is provided and the wound cover by itself may be considered the wound dressing. The wound dressing can then be connected, via the conduit 108, to a source of negative pressure of the wound therapy device 110’. In some cases, though not required, the wound therapy device 110’ can be miniaturized and portable, although larger conventional negative pressure sources (or pumps) can also be used.

[0044] The wound cover 106 can be located over a wound site to be treated. The wound cover 106 can form a substantially sealed cavity or enclosure over the wound. The wound cover 106 can have a film having a high water vapour permeability to enable the evaporation of surplus fluid, and can have a superabsorbing material contained therein to safely absorb wound exudate. In some cases, the components of the TNP systems described herein can be particularly suited for incisional wounds that exude a small amount of wound exudate.

[0045] The wound therapy device 110’ can operate with or without the use of an exudate canister. In some cases, as is illustrated, the wound therapy device 110’ can include an exudate canister. In some cases, configuring the wound therapy device 110’ and conduit 108’ so that the conduit 108’ can be quickly and easily removed from the wound therapy device 110’ can facilitate or improve the process of wound dressing or pump changes, if necessary. Any of the pump assemblies disclosed herein can have any suitable connection between the conduit 108’ and the pump.

[0046] The wound therapy device 110’ can deliver negative pressure of approximately -80 mmHg, or between about -20 mmHg and -200 mmHg. Note that these pressures are relative to normal ambient atmospheric pressure thus, -200 mmHg would be about 560 mmHg in practical terms. In some cases, the pressure range can be between about -40 mmHg and -150 mmHg. Alternatively, a pressure range of up to -75 mmHg, up to -80 mmHg or over -80 mmHg can be used. Also in some cases a pressure range of below -75 mmHg can be used. Alternatively, a pressure range of over approximately -100 mmHg, or even -150 mmHg, can be supplied by the wound therapy device 110’.

[0047] As will be described in greater detail below, the negative pressure wound treatment system 100’ can be configured to provide a connection 332 to a separate or remote computing device 334. The connection 332 can be wired or wireless (such as, Bluetooth, Bluetooth low energy (BLE), Near-Field Communication (NFC), WiFi, or cellular). The remote computing device 334 can be a smartphone, a tablet, a laptop or another standalone computer, a server (such as, a cloud server), another pump device, or the like.

[0048] Figure IB illustrates another negative pressure wound treatment system 100. The negative pressure wound treatment system 100 can have any of the components, features, or other details of any of the other negative pressure wound treatment system disclosed herein, including without limitation the negative pressure wound treatment system 100’ illustrated in Figure 1A or the negative pressure wound treatment system 400 illustrated in Figure 4, in combination with or in place of any of the components, features, or other details of the negative pressure wound treatment system 100 shown in Figure IB and/or described herein. The negative pressure wound treatment system 100 can have a wound cover 106 over a wound 104 that can seal the wound 104. A conduit 108, such as a single or multi lumen tube can be used to connect the wound cover 106 with a wound therapy device 110 (sometimes as a whole or partially referred to as a “pump assembly”) configured to supply reduced or negative pressure. The wound cover 106 can be in fluidic communication with the wound 104.

[0049] With reference to Figure IB, the conduit 108 can have a bridge portion 130 that can have a proximal end portion and a distal end portion (the distal end portion being closer to the wound 104 than the proximal end portion, and an applicator 132 at the distal end of the bridge portion 130 forming the flexible suction adapter (or conduit) 108. A connector 134 can be disposed at the proximal end of the bridge portion 130, so as to connect to at least one of the channels that can extend along a length of the bridge portion 130 of the conduit 108 shown in Figure IB. A cap 140 can be coupled with a portion of the conduit 108 and can, in some cases, as illustrated, be attached to the connector 134. The cap 140 can be useful in preventing fluids from leaking out of the proximal end of the bridge portion 130. The conduit 108 can be a Soft Port manufactured by Smith & Nephew. As mentioned, the negative pressure wound treatment system 100 can include a source of negative pressure, such as the device 110, capable of supplying negative pressure to the wound 104 through the conduit 108. Though not required, the device 110 can also include a canister or other container for the storage of wound exudates and other fluids that can be removed from the wound.

[0050] The device 110 can be connected to the connector 134 via a conduit or tube 142. In use, the applicator 132 can be placed over an aperture formed in a cover 106 that is placed over a suitably -prepared wound or wound 104. Subsequently, with the wound therapy device 110 connected via the tube 142 to the connector 134, the wound therapy device 110 can be activated to supply negative pressure to the wound. Application of negative pressure can be applied until a desired level of healing of the wound is achieved.

[0051] The bridge portion 130 can comprise an upper channel material or layer positioned between an upper layer and an intermediate layer, with a lower channel material or layer positioned between the intermediate layer and a bottom layer. The upper, intermediate, and lower layers can have elongate portions extending between proximal and distal ends and can include a material that is fluid-impermeable, for example polymers such as polyurethane. It will of course be appreciated that the upper, intermediate, and lower layers can each be constructed from different materials, including semi-permeable materials. In some cases, one or more of the upper, intermediate, and lower layers can be at least partially transparent. In some instances, the upper and lower layers can be curved, rounded or outwardly convex over a majority of their lengths.

[0052] The upper and lower channel layers can be elongate layers extending from the proximal end to the distal end of the bridge 130 and can each preferably comprise a porous material, including for example open-celled foams such as polyethylene or polyurethane. In some cases, one or more of the upper and lower channel layers can be comprised of a fabric, for example a knitted or woven spacer fabric (such as a knitted polyester 3D fabric, Baltex 7970.RTM., or Gehring 879.RTM.) or a nonwoven material, or terry-woven or loop-pile materials. The fibers may not necessarily be woven, and can include felted and flocked (including materials such as Flotex.RTM.) fibrous materials. The materials selected are preferably suited to channeling wound exudate away from the wound and for transmitting negative pressure or vented air to the wound site, and can also confer a degree of kinking or occlusion resistance to the channel layers. In one example, the upper channel layer can include an open-celled foam such as polyurethane, and the lower channel layer can include a fabric. In another example, the upper channel layer is optional, and the system can instead be provided with an open upper channel. The upper channel layer can have a curved, rounded or upwardly convex upper surface and a substantially flat lower surface, and the lower channel layer can have a curved, rounded or downwardly convex lower surface and a substantially flat upper surface.

[0053] The fabric or material of any components of the bridge 130 can have a three-dimensional (3D) structure, where one or more types of fibers form a structure where the fibers extend in all three dimensions. Such a fabric can in some cases aid in wicking, transporting fluid or transmitting negative pressure. In some cases, the fabric or materials of the channels can include several layers of material stacked or layered over each other, which can in some cases be useful in preventing the channel from collapsing under the application of negative pressure. The materials used in some implementations of the conduit 108 can be conformable and pliable, which can, in some cases, help to avoid pressure ulcers and other complications which can result from a wound treatment system being pressed against the skin of a patient.

[0054] The distal ends of the upper, intermediate, and lower layers and the channel layers can be enlarged at their distal ends (to be placed over a wound site), and can form a "teardrop" or other enlarged shape. The distal ends of at least the upper, intermediate, and lower layers and the channel layers can also be provided with at least one through aperture. This aperture can be useful not only for the drainage of wound exudate and for applying negative pressure to the wound, but also during manufacturing of the device, as these apertures can be used to align these respective layers appropriately.

[0055] In some implementations, a controlled gas leak 146 (sometimes referred to as gas leak, air leak, or controlled air leak) can be disposed on the bridge portion 130, for example at the proximal end thereof. This air leak 146 can comprise an opening or channel extending through the upper layer of the bridge portion 130, such that the air leak 146 is in fluidic communication with the upper channel of the bridge portion 130. Upon the application of suction to the conduit 108, gas (such, as air) can enter through the gas leak 146 and move from the proximal end of the bridge portion 130 to the distal end of the bridge portion along the upper channel of the bridge portion 130. The gas can then be suctioned into the lower channel of the bridge portion 130 by passing through the apertures through the distal ends of the upper, intermediate, and lower layers.

[0056] The air leak 146 can include a filter. Preferably, the air leak 146 is located at the proximal end of the bridge portion 130 so as to minimize the likelihood of wound exudate or other fluids coming into contact and possibly occluding or interfering with the air leak 146 or the filter. In some instances, the filter can be a microporous membrane capable of excluding microorganisms and bacteria, and which may be able to filter out particles larger than 45 pm. Preferably, the filter can exclude particles larger than 1.0 pm, and more preferably, particles larger than 0.2 pm. Advantageously, some implementations can provide for a filter that is at least partially chemically-resistant, for example to water, common household liquids such as shampoos, and other surfactants. In some cases, reapplication of vacuum to the suction adapter or wiping of the exposed outer portion of the filter may be sufficient to clear any foreign substance occluding the filter. The filter can be composed of a suitably-resistant polymer such as acrylic, polyethersulfone, or polytetrafluoroethylene, and can be oleophobic or hydrophobic. In some cases, the gas leak 146 can supply a relatively constant gas flow that does not appreciably increase as additional negative pressure is applied to the conduit 108. In instances of the negative pressure wound treatment system 100 where the gas flow through the gas leak 146 increases as additional negative pressure is applied, preferably this increased gas flow will be minimized and not increase in proportion to the negative pressure applied thereto. Further description of such bridges, conduits, air leaks, and other components, features, and details that can be used with any implementations of the negative pressure wound treatment systems disclosed herein are found in U.S. Patent No. 8,801,685, which is incorporated by reference in its entirety as if fully set forth herein.

[0057] Any of the wound therapy devices (such as, the device 110 or 110’) disclosed herein can provide continuous or intermittent negative pressure therapy. Continuous therapy can be delivered at above 0 mmHg, -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -125 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, -200 mmHg, or below -200 mmHg. Intermittent therapy can be delivered between low and high negative pressure set points (sometimes referred to as setpoint). Low set point can be set at above 0 mmHg, -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -125 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, or below -180 mmHg. High set point can be set at above - 25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -125 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, -200 mmHg, or below -200 mmHg. During intermittent therapy, negative pressure at low set point can be delivered for a first time duration, and upon expiration of the first time duration, negative pressure at high set point can be delivered for a second time duration. Upon expiration of the second time duration, negative pressure at low set point can be delivered. The first and second time durations can be same or different values.

[0058] In operation, the wound filler 102 can be inserted into the cavity of the wound 104, and wound cover 106 can be placed so as to seal the wound 104. The wound therapy device 110’ can provide negative pressure to the wound cover 106, which can be transmitted to the wound 104 via the wound filler 102. Fluid (such as, wound exudate) can be drawn through the conduit 108’ and stored in a canister. In some cases, fluid is absorbed by the wound filler 102 or one or more absorbent layers (not shown). [0059] Wound dressings that can be utilized with the pump assembly and systems of the present application include Renasys-F, Renasys-G, Renasys AB, and Pico Dressings available from Smith & Nephew. Further description of such wound dressings and other components of a negative pressure wound therapy system that can be used with the pump assembly and systems of the present application are found in U.S. Patent Publication Nos. 2012/0116334, 2011/0213287, 2011/0282309, 2012/0136325, U.S. Patent No. 9,084,845, and International App. No. PCT/EP2020/078376, each of which is incorporated by reference in its entirety as if fully set forth herein. In some cases, other suitable wound dressings can be utilized.

[0060] The negative pressure wound therapy device 110 may include a pump assembly and canister. The pump assembly and cannister can be connected, thereby forming the wound therapy device 110. The pump assembly can include an interface panel having a display, one or more indicators, or one or more controls or buttons, including, for example and without limitation, a therapy start and pause button or an alarm/alert mute button. The interface panel can have one or more input controls or buttons 184 that can be used to control any functions of the pump assembly or the interface panel. For example and without limitation, one or more of the buttons can be used to turn the pump assembly on or off, to start or pause therapy, to operate and monitor the operation of the pump assembly, to scroll through menus displayed on the display, or to control or perform other functions. In some cases, the command buttons can be programmable, and can be made from a tactile, soft rubber.

[0061] Additionally, the interface panel can have visual indicators that can indicate which of the one or more buttons is active. The interface panel can also have a lock/unlock control or button that can be configured to selectively lock or unlock the functionality of the various buttons or the display. For example, therapy setting adjustment can be locked/unlocked via the lock/unlock control. When the lock/unlock button is in the locked state, depressing one or more of the various other buttons or the display will not cause the pump assembly to change any display functions or performance functions of the device. This way, the interface panel will be protected from inadvertent bumping or touching of the various buttons or display. The interface panel can be located on an upper portion of the pump assembly, for example and without limitation on an upward facing surface of the pump assembly.

[0062] The display, which can be a screen such as an LCD screen, can be mounted in a middle portion of the interface panel. The display can be a touch screen display. The display can support playback of audiovisual (AV) content, such as instructional videos, and render a number of screens or graphical user interfaces (GUIs) for configuring, controlling, and monitoring the operation of the pump assembly.

[0063] The one or more indicators can be lights (such as, LEDs) and can be configured to provide a visual indication of alarm conditions and or a status of the pump. For example and without limitation, the one or more indicators can be configured to provide a visual indication of a status of the pump assembly or other components of the negative pressure wound treatment system 100, including without limitation the conduit 108 or the wound cover 106 (such as, to provide an indication of normal operation, low battery, a leak, canister full, blockage, overpressure, or the like). Any one or more suitable indicators can be additionally or alternatively used, such as visual, audio, tactile indicator, and so on.

[0064] The pump assembly of the wound therapy device 110 can include a speaker for producing sound. For example and without limitation, the speaker can generate an acoustic alarm in response to deviations in therapy delivery, non-compliance with therapy delivery, or any other similar or suitable conditions or combinations thereof. The speaker can provide audio to accompany one or more instructional videos that can be displayed on the display.

[0065] The pump assembly can be configured to provide easy access (such as, an access door on the casing of the pump assembly) to one or more filters of the pump assembly, such as antibacterial filters. This can enable a user (such as, a healthcare provider or patient) to more easily access, inspect or replace such filters. The pump assembly can also include a power jack for providing power to the pump assembly or for charging and recharging an internal power source (such as, a battery). Some implementations of the pump assembly can include a disposable or renewable power source, such as one or more batteries, so that no power jack is needed. The pump assembly can have a recess formed therein to facilitate gripping of the pump assembly. [0066] The canister can hold fluid aspirated from the wound 104. For example, the canister can have an 800 mL (or approximately 800 mL) capacity, or from a 300 mL or less capacity to a 1000 mL or more capacity, or any capacity level in this range. The canister can include a tubing for connecting to the conduit 108 in order to form a fluid flow path. The canister can be replaced with another canister, such as when the canister has been filled with fluid. The wound therapy device 110 can include a canister inlet tube 142 (also referred to herein as a dressing port connector) in fluid communication with the canister. For example and without limitation, the canister inlet tube 142 can be used to connect with the conduit 108.

[0067] The canister can be selectively coupleable and removable from the pump assembly. In some cases, a canister release button can be configured to selectively release the canister from the pump assembly. The canister can have one or more fill lines or graduations to indicate to the user and amount of fluid or exudate stored within the canister.

[0068] The wound therapy device 110 can have a handle that can be used to lift or carry the wound therapy device 110. The handle can be coupled with the pump assembly and can be rotatable relative to the wound therapy device 110 so that the handle can be rotated upward for lifting or carrying the wound therapy device 110 or the pump assembly, or rotated into a lower profile in a more compact position when the handle is not being used. In some cases, the handle can be coupled with the pump assembly in a fixed position. The handle can be coupled with an upper portion of the pump assembly or can be removable from the wound therapy device 110.

[0069] A control system can be employed in any of the wound therapy devices described herein, such as in the wound therapy device 110. Electrical components can operate to accept user input, provide output to the user, operate the pressure source, provide connectivity, and so on. A first processor (such as, a main controller) can be responsible for user activity, and a second processor (such as, a pump controller) can be responsible for controlling another device, such as a pump.

[0070] An input/output (I/O) module can be used to control an input and/or output to another component or device, such as the pump, one or more sensors (for example, one or more pressure sensors configured to monitor pressure in one or more locations of the fluid flow path), or the like. For example, the I/O module can receive data from one or more sensors through one or more ports, such as serial (for example, I2C), parallel, hybrid ports, and the like. Any of the pressure sensors can be part of the wound therapy device or the canister. In some cases, any of the pressure sensors can be remote to the wound therapy device, such as positioned at or near the wound (for example, in the dressing or the conduit connecting the dressing to the wound therapy device). In such implementations, any of the remote pressure sensors can communicate with the I/O module over a wired connection or with one or more transceivers over a wireless connection.

[0071] The main controller can receive data from and provide data to one or more expansion modules, such as one or more USB ports, SD ports, Compact Disc (CD) drives, DVD drives, FireWire ports, Thunderbolt ports, PCI Express ports, and the like. The main controller, along with other controllers or processors, can store data in memory (such as one or more memory modules), which can be internal or external to the main controller. Any suitable type of memory can be used, including volatile or non-volatile memory, such as RAM, ROM, magnetic memory, solid-state memory, Magnetoresistive random-access memory (MRAM), and the like.

[0072] The main controller can be a general purpose controller, such as a low- power processor or an application specific processor. The main controller can be configured as a “central” processor in the electronic architecture of the control system, and the main controller can coordinate the activity of other processors, such as the pump controller, one or more communications controllers, and one or more additional processors. The main controller can run a suitable operating system, such as a Linux, Windows CE, VxWorks, etc.

[0073] The pump controller can control the operation of a pump, which can generate negative or reduced pressure. The pump can be a suitable pump, such as a diaphragm pump, peristaltic pump, rotary pump, rotary vane pump, scroll pump, screw pump, liquid ring pump, diaphragm pump operated by a piezoelectric transducer, voice coil pump, and the like. The pump controller can measure pressure in a fluid flow path, using data received from one or more pressure sensors, calculate the rate of fluid flow, and control the pump. The pump controller can control the pump actuator (such as, a motor) so that a desired level of negative pressure is achieved in the wound 104. The desired level of negative pressure can be pressure set or selected by the user. The pump controller can control the pump (for example, pump motor) using pulse-width modulation (PWM) or pulsed control. A control signal for driving the pump can be a 0-100% duty cycle PWM signal. The pump controller can perform flow rate calculations and detect alarms. The pump controller can communicate information to the main controller. The pump controller can be a low- power processor.

[0074] Any of the one or more communications controllers can provide connectivity (such as, a wired or wireless connection). The one or more communications controllers can utilize one or more transceivers for sending and receiving data. The one or more transceivers can include one or more antennas, optical sensors, optical transmitters, vibration motors or transducers, vibration sensors, acoustic sensors, ultrasound sensors, or the like. Any of the one or more transceivers can function as a communications controller. In such case, the one or more communications controllers can be omitted. Any of the one or more transceivers can be connected to one or more antennas that facilitate wireless communication. The one or more communications controllers can provide one or more of the following types of connections: Global Positioning System (GPS), cellular connectivity (for example, 2G, 3G, LTE, 4G, 5G, or the like), NFC, Bluetooth connectivity (or BLE), radio frequency identification (RFID), wireless local area network (WLAN), wireless personal area network (WPAN), WiFi connectivity, Internet connectivity, optical connectivity (for example, using infrared light, barcodes, such as QR codes, etc.), acoustic connectivity, ultrasound connectivity, or the like. Connectivity can be used for various activities, such as pump assembly location tracking, asset tracking, compliance monitoring, remote selection, uploading of logs, alarms, and other operational data, and adjustment of therapy settings, upgrading of software or firmware, pairing, and the like.

[0075] Any of the one or more communications controllers can provide dual GPS/cellular functionality. Cellular functionality can, for example, be 3G, 4G, or 5G functionality. The one or more communications controllers can communicate information to the main controller. Any of the one or more communications controllers can include internal memory or can utilize memory. Any of the one or more communications controllers can be a low-power processor.

[0076] The control system can store data, such as GPS data, therapy data, device data, and event data. This data can be stored, for example, in memory. This data can include patient data collected by one or more sensors. The control system can track and log therapy and other operational data. Such data can be stored, for example, in the memory.

[0077] Using the connectivity provided by the one or more communications controllers, the control system can upload any of the data stored, maintained, or tracked by the control system to a remote computing device, such as the device. The control system can also download various operational data, such as therapy selection and parameters, firmware and software patches and upgrades, and the like (for example, via the connection to the device). The one or more additional processors, such as processor for controlling one or more user interfaces (such as, one or more displays), can be utilized. In some cases, any of the illustrated or described components of the control system can be omitted depending on an embodiment of a wound monitoring or treatment system in which the control system is used.

[0078] Any of the negative pressure wound therapy devices described herein can include one or more features disclosed in U.S. Patent No. 9,737,649 or U.S. Patent Publication No. 2017/0216501, each of which is incorporated by reference in its entirety.

Multiple Dressing Negative Wound Therapy

[0079] In some embodiments, the negative pressure wound treatment system can include a wound therapy device capable of supplying negative pressure to the wound site or sites, such as wound therapy device 110. The wound therapy device 110 can be in fluidic communication with one or more wound dressings so as to supply negative pressure to one or more wounds. A first fluid flow path can include components providing fluidic connection from the wound therapy device 110 to the first wound dressing. As a non-limiting example, the first fluid flow path can include the path from the first wound dressing to the wound therapy device 110 or the path from the first wound dressing to an inlet of a branching attachment (or connector) in fluidic connection with the wound therapy device 110. Similarly, a second fluid flow path can include components providing fluidic connection from the wound therapy device 110 to the second wound dressing.

[0080] The system can be similar to the system 100 with the exception that multiple wounds are being treated by the system. The system can include any one or more of the components of the system 100, such as, one or more wounds 104 and one or more covers 106. The system can include a plurality of wound dressings (and corresponding fluid flow paths) in fluidic communication with the wound therapy device 110 via a plurality of suction adapters, such as the adapter 108. The suction adapters can include any one or more of the components of the adapter 108, such as, one or more bridge portions 130, one or more connectors 134, and one or more caps 140).

[0081] The wound therapy device 110 can be fluidically coupled via the tube 142 with the inlet of the connector. The connector can be fluidically coupled via branches and tubes or conduits with the connectors 134, which can be fluidically coupled with the tubes or conduits 130. The tubes or conduits 130 can be fluidically coupled with the dressings 106. Once all conduits and dressing components are coupled and operably positioned, the wound therapy device 110 can be activated, thereby supplying negative pressure via the fluid flow paths to the wounds 104a, 104b. Application of negative pressure can be applied until a desired level of healing of the wounds 104 is achieved. Although two wounds and wound dressing are described, some implementations of the wound therapy device 110 can provide treatment to a single wound (for instance, by closing the unused branch of the connector) or to more than two wounds (for instance, by adding branches to the connector).

[0082] The system can include one or more features disclosed in U.S. Patent Publication No. 2020/0069850 or International Publication No. WO2018/167199, each of which is incorporated by reference in its entirety.

Wound Filler Conglomerate

[0083] Figure 2 illustrates an embodiment of a wound filler conglomerate 200, which may also be referred to as a customizable wound dressing or a modular wound dressing throughout the specification. The wound filler conglomerate 200 may be used with a negative pressure wound therapy system such as those described earlier in the specification. The wound filler conglomerate 200 can include a wound filler 202 and a wound contact layer 204. The wound filler 202 may be enclosed, or partially enclosed, by the wound contact layer 204. As more fully described below, embodiments of the wound filler conglomerate 200 can include various shapes, sizes, and materials.

[0084] As depicted in Figure 2, the wound filler conglomerate 200 may include individual modules 206, which may also be referred to as units, pockets, or building blocks. A customizable or modular wound filler conglomerate 200 may advantageously assist in customizing the wound filler conglomerate 200 to accommodate wounds of various shapes and/or sizes. A customizable wound filler conglomerate 200 may assist in reducing or eliminating the need to cut the wound filler to size and/or shape, thereby reducing preparation time an d reducing the risk of fibers or particulates being shed into the wound. The wound filler conglomerate 200 may include one, two, three, four, five, six, seven, eight, nine, ten, or any combination thereof of modules 206.

[0085] Figure 2 depicts an embodiment of a wound filler conglomerate 200 in which the modules 206 have a square cross section. In particular embodiments, the modules 206 may have a rectangular, circular, oval, oblong, polygonal, or any other suitably shaped cross section. Figure 2 depicts an embodiment of a wound filler conglomerate 200 in which the modules 206 are the same shape. In embodiments, the modules 206 may vary in shape. Further, Figure 2 depicts an embodiment of a wound filler conglomerate 200 in which the modules 206 are substantially the same size. In some embodiments, the modules 206 may vary in size.

[0086] In certain examples, the wound filler 202 may be foam. In certain embodiments, the wound filler 202 may be gauze, non-woven material, spacer fabric, wool, polymer beads, absorbent material, porous material, or any combination thereof. One of skill in the art will understand that the filler material may be any material suitable for use in negative pressure wound therapy.

[0087] Figure 3 illustrates an embodiment of the wound contact layer 204. The wound contact layer 204 may be silicone. In some embodiments, the wound contact layer 204 may include polyurethane or any other suitable material. The wound contact layer 204 may be transparent. In certain examples, the wound contact layer 204 may be opaque. As depicted in Figure 3, the wound contact layer 204 may be perforated. Perforations 300 in the wound contact layer 204 may permit fluid to flow through the wound contact layer. For example, perforations 300 in the wound contact layer 204 may permit wound exudate to flow through the wound contact layer 204 and subsequently through the wound filler material 202 when negative pressure is applied to the wound site. Perforations 300 may also enable or facilitate the transmission of negative pressure through the wound cavity and to the wound base, or wound surface. Perforations 300 in the wound contact layer 204 may be circular, oval, oblong, square, rectangular, polygonal, or of any suitable shape. Perforations 300 may be arranged in any suitable pattern. Figure 3 illustrates an embodiment in which adjacent perforations are substantially aligned. In other embodiments, perforations 300 may be arranged in a staggered pattern. Perforations 300 may be uniform in size. Perforations 300 may be of various sizes, such as having a diameter from about: .1 to 20 mm, 1-10mm, 2- 8mm, 2.5mm to 5mm, or about 3mm. One of skill in the art will understand that in certain examples, the perforations may be non-uniform, meaning that perforations may have different diameters within a single layer.

[0088] Figure 4 illustrates an example of a wound filler conglomerate 200 placed in a wound 104. As depicted in Figure 4, the wound filler conglomerate 200 may be positioned such that the wound filler conglomerate 200 substantially conforms to the wound 104. For example, the wound filler conglomerate 200 may be positioned such that it substantially fills the cavity of the wound 104. The conformability of the wound filler conglomerate 200 may advantageously reduce or eliminate the need to cut the wound filler to size and/or shape, thereby reducing preparation time and reducing the risk of wound filler fibers or particulates being shed into the wound.

[0089] As depicted in Figure 4, the wound filler conglomerate 200 may be positioned in the wound 104 such that the wound contact layer 204 contacts the wound 104, and the filler material 202 does not contact the wound 104. This approach may advantageously reduce the risk of wound filler fibers or particulates being shed into the wound, thereby reducing pain and/or irritation potentially inflicted on the patient during removal of the wound filler conglomerate 200, and reducing the risk of removal of healthy granulated tissue during removal of the wound filler conglomerate 200.

[0090] Figure 5 illustrates another example of a wound filler conglomerate 200 placed in a wound 104 having a tunneling feature 500. As depicted in Figure 5, the conformability or customizability of the wound filler conglomerate 200 may allow the wound filler conglomerate 200 to be placed into wounds having various geometric features, such as the tunneling feature 500 depicted in Figure 5. Placing the wound filler conglomerate 200 into a tunneling feature 500 may advantageously assist in applying negative pressure to the wound area, including the tunneling feature 500. Further, placing the wound filler conglomerate 200 into a tunneling feature 500 may reduce the risk of the tunneling feature collapsing, rupturing, or otherwise sustaining further damage during application of negative pressure.

[0091] As depicted in Figure 6, another example of a wound filler conglomerate 200 may be further customized by separating, or disconnecting, one or more individual modules 206 from the wound filler conglomerate 200. For example, individual units of wound filler material 202 may be enclosed, or partially enclosed, within pockets of the wound contact layer 204, forming modules 206. The modules 206 may be removably connected to each other by connections 600, which may be formed by wound contact layer 204. The wound contact layer 204 may be perforated, which may advantageously assist with separation of modules 206 from each other. In other embodiments, a module 206 may be separated by cutting, tearing, or otherwise disconnecting the module 206 from the wound filler conglomerate 200.

[0092] Figure 7A illustrates a wound filler conglomerate 200 having multiple modules 206 removably connected to each other by connections 600. As will be understood by one of skill in the art, such connections may also be included in the embodiments of Figures 2-6. As depicted in Figure 7A, individual units of filler material 202 may be enclosed, or partially enclosed, within pockets of the wound contact layer 204, forming modules 206. A module 206 may be removably connected to an adjacent module 206 by connection 600. As discussed above and as depicted in Figure 6, connections 600 may include perforated wound contact layer 204 or other suitable structures. For example, connections 600 may include two layers, or films, of perforated contact layer 204 adhered to each other. Connections 600 formed from perforated contact layer 204 may have perforations to assist with separation or disconnection. Perforations of connection 600 may include any suitable dimensions. In some embodiments, perforations of connection 600 may be of various sizes, such as having a diameter from about: .1 to 20 mm, 1-10 mm, 2-8 mm, 2.5 mm to 5 mm, or about 3mm. In some embodiments, adjacent perforations of connection 600 may be separated by about: 1 mm, 2 mm, 3 mm, 4 mm, 5mm, 6mm or any suitable dimension. One of skill in the art will understand that various separations between perforations may lead to more or less tearing, for example large gaps between perforations may lead to decreased tearing. In embodiments, connections 600 may include cord, string, synthetic polymers, collagen threads, or other suitable materials for connecting modules 206. In some embodiments, connections 600 of a single wound filler conglomerate 200 may all be the same material. In certain embodiments, connections 600 of a single wound filler conglomerate 200 may include various materials.

[0093] As depicted in Figure 7B, the wound filler conglomerate 200 may be further customized by disconnecting connection 600, thereby separating, or disconnecting, one or more individual modules 206 from the wound filler conglomerate 200. For example, a module 206 may be separated from the wound filler conglomerate 200 by cutting, tearing, or otherwise disconnecting connection 600.

[0094] As depicted in Figure 7C, the material forming the connections 600 may cause the connections to have a stiffness. The stiffness of connections 600 may allow the modules 206 to be manipulated or formed to correspond to various shaped wounds. In some embodiments, connections 600 of a single wound filler conglomerate 200 may have a substantially uniform stiffness. In other embodiments, connections 600 of a single wound filler conglomerate 200 may have varying stiffnesses.

[0095] Figure 8 A illustrates another embodiment of a wound filler conglomerate 200. As previously discussed, various embodiments of the wound filler conglomerate 200 may have various shapes and/or sizes. As depicted in Figure 8A, the wound filler conglomerate 200 may include strips of wound filler 202. The strips of wound filler 202 may be enclosed, or partially enclosed, by wound contact layer 204. The wound filler conglomerate 200 may include one or more modules 206. Adjacent modules 206 may be removably connected to each other by one or more connections 600.

[0096] Figure 8B illustrates another view of the wound filler conglomerate 200 of Figure 8 A. As depicted in Figure 8B, the wound filler conglomerate 200 may be manipulated or formed into various shapes or geometric configurations. For example, as depicted in Figure 8B, the wound filler conglomerate 200 may be rolled or otherwise manipulated into a spiraled configuration. In other embodiments, the wound filler conglomerate 200 may be twisted, compressed, stretched, curled, or otherwise formed into various shapes and/or sizes. Rolling or otherwise manipulating the wound filler conglomerate 200 may advantageously assist with efficient storage. Further, rolling or otherwise manipulating the wound filler conglomerate 200 may assist with application of the wound filler conglomerate 200 to wounds of various shapes and sizes. [0097] Figures 9 through 15 illustrate various embodiments of a wound filler conglomerate 200. As depicted in Figures 9 through 15, embodiments of the wound filler conglomerate 200 may include various sizes, shapes, and/or configurations. The various embodiments of the wound filler conglomerate 200 may advantageously allow the wound filler conglomerate 200 to be formed, manipulated, arranged, and/or applied to wounds of various shapes and sizes. One of skill in the art will understand that, while Figures 9 through 15 illustrate various sizes, shapes, and/or configurations of a wound filler conglomerate 200, they are disclosed as non-limiting examples. The wound filler conglomerate 200 may be applied in any suitable configuration or arrangement to a wound. It should be further understood that any suitable number of wound filler conglomerates 200 may be applied to a wound. For example, 2, 3, 4, or more wound filler conglomerates may be applied to a wound.

[0098] Figure 9 illustrates an embodiment of a wound filler conglomerate 200 in which individual modules 206 are applied to a wound 104. As depicted in Figure 9, the modules 206 may be loosely or freely applied to the wound 104. The modules 206 may be applied to the wound 104 such that the modules 206 loosely or freely fill the wound 104. The modules 206 may be applied to the wound 104 such that the modules 206 substantially, or at least partially, fill the cavity of the wound 104. Figure 9 depicts an embodiment in which the modules 206 have a square cross section. As previously discussed, in other embodiments, the modules 206 may have a rectangular, circular, oval, oblong, polygonal, or any other suitably shaped cross section.

[0099] Figure 10 illustrates an embodiment of a wound filler conglomerate 200 in which individual modules 206 are applied to a wound 104. As depicted in Figure 10, the modules 206 may be applied in a layered configuration to the wound 104. The wound 104 may be substantially or partially filled with modules 206 of varying sizes and/or shape. For example, larger modules 206 may first be placed into the wound 104. Smaller modules 206 may then be placed into the wound 104 such that the modules 206 substantially, or at least partially, fill the cavity of the wound 104.

[0100] Figure 11 illustrates an embodiment in which a wound filler conglomerate 200 is applied in a layered configuration to a wound 104. As depicted in Figure 11, the wound filler conglomerate 200 may be configured as a tape, sheet, strip, or rope, which may be applied in a layered configuration to the wound 104 such that the wound filler conglomerate 200 substantially, or at least partially, fills the cavity of the wound 104. The tape, sheet, stripe, or rope wound filler conglomerate 200 may have a square, rectangular, oval, oblong, polygonal, or any other suitably shaped cross section.

[0101] Figure 12 illustrates an embodiment in which a wound filler conglomerate 200 is applied in a rolled configuration to a wound 104. As depicted in Figure 12, the wound filler conglomerate 200 may be configured as a tape, sheet, strip, or rope, which may be applied in a rolled configuration to the wound 104 such that the wound filler conglomerate 200 substantially, or at least partially, fills the cavity of the wound 104.

[0102] Figure 13 illustrates an embodiment in which a wound filler conglomerate 200 is applied in a spiraled configuration to a wound 104. As depicted in Figure 13, the wound filler conglomerate 200 may be configured as a tape, sheet, strip, or rope, which may be applied in a spiraled configuration to the wound 104 such that the wound filler conglomerate 200 substantially, or at least partially, fills the cavity of the wound 104.

[0103] Figure 14 illustrates an embodiment in which a wound filler conglomerate 200 is applied in a gathered, bunched, scrunched, or random configuration to a wound 104. As depicted in Figure 14, the wound filler conglomerate 200 may be configured as a tape, sheet, strip, or rope, which may be applied in a gathered, bunched, scrunched, or random configuration to the wound 104 such that the wound filler conglomerate 200 substantially, or at least partially, fills the cavity of the wound 104.

[0104] Figure 15 illustrates an embodiment in which a wound filler conglomerate 200 is applied in a folded configuration to a wound 104. As depicted in Figure 15, the wound filler conglomerate 200 may be configured as a tape, sheet, strip, or rope, which may be applied in a folded configuration to the wound 104 such that the wound filler conglomerate 200 substantially, or at least partially, fills the cavity of the wound 104.

[0105] Figures 16A through 16B illustrate certain embodiments of a wound filler conglomerate 200. As depicted in Figure 16A, and as previously discussed, the wound filler conglomerate 200 can include a filler material 202 and a wound contact layer 204. The filler material 202 may be enclosed, or partially enclosed, by the wound contact layer 204. In some embodiments and as a non-limiting example, the filler material 202 may include Pico® spacer material, such as is present in Pico wound dressings sold by Smith + Nephew. One of skill in the art will understand that such material may be used as the wound filler material in the embodiments described in relation to Figures 2-15. In some embodiments, the wound contact layer 204 may include silicone, polyurethane, or any other suitable material. The wound contact layer 204 may be perforated. As depicted in Figure 16A, the wound filler conglomerate 200 may include modules 206 removably connected to each other by connections 600. Connections 600 may include perforated contact layer 204. For example, connections 600 may include two layers, or films, of perforated contact layer 204 adhered to each other. Perforations of connection 600 may include any suitable dimensions. In some embodiments, perforations of connection 600 may be approximately 3 mm long. In some embodiments, adjacent perforations of connection 600 may be separated by 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, or any suitable dimension. One of skill in the art will understand that various separations between perforations may lead to more or less tearing, for example large gaps between perforations may lead to decreased tearing. Further, one of skill in the art will also understand that the extensibility of a material, such as film may affect the tearability of perforations.

[0106] As depicted in Figure 16B, the wound filler conglomerate 200 may have modules 206 of various shapes, sizes, and configurations. For example, Figure 16B illustrates an embodiment of a wound filler conglomerate 200 having a large hexagonal module and multiple smaller triangular modules 206 surrounding the hexagonal module. It should be understood that the embodiment of Figure 16B is disclosed as a non-limiting example. The wound filler conglomerate 200 may include any number of modules 206 having any suitable shape, size, or configuration. As a non-limiting example, the wound filler conglomerate 200 may include only a plurality of triangular modules 206, thereby creating a sheet of alternating triangles. The wound filler conglomerate 200, for example, as depicted in Figures 16A-16B, may be applied to a wound. The wound filler conglomerate 200 may be applied to the wound such that the wound contact layer 204 contact the wound and the filler material 202 does not contact the wound. Further, foam or another bulk filler material may be used to fill in the remainder of the wound cavity. The foam or other bulk filler material may be positioned such that it contacts the wound filler conglomerate 200, and the wound contact layer 204 of the wound filler conglomerate 200 contacts the wound. [0107] In some embodiments, the wound filler conglomerate 200 depicted in Figures 16A through 16B may be applied, as a non-limiting example, as an advanced organ protection layer in abdomen kits.

Other Variations

[0108] Although some embodiments describe negative pressure wound therapy, the systems, devices, and/or methods disclosed herein can be applied to other types of therapies usable standalone or in addition to TNP therapy. Systems, devices, and/or methods disclosed herein can be extended to any medical device, and in particular any wound monitoring and/or treatment device. For example, systems, devices, and/or methods disclosed herein can be used with devices that provide one or more of ultrasound therapy, oxygen therapy, neurostimulation, microwave therapy, active agents, antibiotics, antimicrobials, or the like. Such devices can in addition provide TNP therapy. As another example, systems, devices, and/or methods disclosed herein can be used with a wound debridement system, patient monitoring system, or the like. The systems and methods disclosed herein are not limited to medical devices and can be utilized by any electronic device.

[0109] Any of transmission of data described herein can be performed securely. For example, one or more of encryption, https protocol, secure VPN connection, error checking, confirmation of delivery, or the like can be utilized.

[0110] Any value of a threshold, limit, duration, etc. provided herein is not intended to be absolute and, thereby, can be approximate. In addition, any threshold, limit, duration, etc. provided herein can be fixed or varied either automatically or by a user. Furthermore, as is used herein relative terminology such as exceeds, greater than, less than, etc. in relation to a reference value is intended to also encompass being equal to the reference value. For example, exceeding a reference value that is positive can encompass being equal to or greater than the reference value. In addition, as is used herein relative terminology such as exceeds, greater than, less than, etc. in relation to a reference value is intended to also encompass an inverse of the disclosed relationship, such as below, less than, greater than, etc. in relations to the reference value. [0111] Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, can be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0112] While certain embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of protection. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions and changes in the form of the methods and systems described herein may be made. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the processes illustrated and/or disclosed may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, others may be added. For example, the actual steps and/or order of steps taken in the disclosed processes may differ from those shown in the figure. Depending on the embodiment, certain of the steps described above may be removed, others may be added. For instance, the various components illustrated in the figures or described herein may be implemented as software and/or firmware on a processor, controller, ASIC, FPGA, and/or dedicated hardware. The software or firmware can include instructions stored in a non-transitory computer-readable memory. The instructions can be executed by a processor, controller, ASIC, FPGA, or dedicated hardware. Hardware components, such as controllers, processors, ASICs, FPGAs, and the like, can include logic circuitry. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. [0113] User interface screens illustrated and described herein can include additional and/or alternative components. These components can include menus, lists, buttons, text boxes, labels, radio buttons, scroll bars, sliders, checkboxes, combo boxes, status bars, dialog boxes, windows, and the like. User interface screens can include additional and/or alternative information. Components can be arranged, grouped, displayed in any suitable order.

[0114] Conditional language used herein, such as, among others, “can,” “could”, “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or states. Thus, such conditional language is not generally intended to imply that features, elements and/or states are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or states are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Further, the term “each,” as used herein, in addition to having its ordinary meaning, can mean any subset of a set of elements to which the term “each” is applied. Additionally, the words “herein,” “above,” "below," and words of similar import, when used in this application, refer to this application as a whole and not to any particular portions of this application.

[0115] Conjunctive language, such as the phrase “at least one of X, Y and Z,” unless specifically stated otherwise, is to be understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z, or a combination thereof. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y and at least one of Z to each be present.

[0116] Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degree.

[0117] Unless otherwise explicitly stated, articles such as “a” or “an” should generally be interpreted to include one or more described items. Accordingly, phrases such as “a device configured to” are intended to include one or more recited devices. Such one or more recited devices can also be collectively configured to carry out the stated recitations.

[0118] Although the present disclosure includes certain embodiments, examples and applications, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and obvious modifications and equivalents thereof, including embodiments which do not provide all of the features and advantages set forth herein. Accordingly, the scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments herein, and may be defined by claims as presented herein or as presented in the future.

Claims

WHAT IS CLAIMED IS:

1. A wound therapy device, comprising: a plurality of modules configured to contact a wound, individual modules comprising a porous wound filler and a wound contact layer, the wound contact layer enclosing the wound filler.

2. The wound therapy device of claim 1, wherein the wound filler and the wound contact layer comprise different materials.

3. The wound therapy device of any one of the previous claims, wherein the wound filler material comprises foam.

4. The wound therapy device of any one of the previous claims, wherein the wound contact layer comprises perforations.

5. The wound therapy device of any one of the previous claims, wherein the wound contact layer comprises silicone.

6. The wound therapy device of any one of the previous claims, wherein the wound contact layer comprises polyurethane.

7. The wound therapy device of any one of the previous claims, wherein the wound contact layer is substantially transparent.

8. The wound therapy device of any one of the previous claims, wherein the modules are removably connected to one other.

9. The wound therapy device of claim Error! Reference source not found., wherein adjacent individual modules are removably connected to each other by a connection component.

10. The wound therapy device of claim 9, wherein the connection component and the contact layer are monolithic.

11. The wound therapy device of claim 9, wherein the connection component comprises cord.

12. The wound therapy device of claim 9, wherein the connection component comprises string.

13. The wound therapy device of claim 9, wherein the connection component comprises a synthetic polymer.

14. The wound therapy device of claim 9, wherein the connection component comprises a plurality of collagen threads.

15. The wound therapy device of any one of the previous claims, further comprising a connection configured to supply a source of negative pressure to a space beneath the wound contact layer.

16. A method of treating a wound, the method comprising: applying a wound therapy device to a wound, the wound therapy device comprising a plurality of modules, individual modules comprising a wound filler enclosed by a wound contact layer, the wound filler comprising a first material and the wound contact layer comprising a second material; and applying negative pressure to a space beneath the wound contact layer.

17. The method of claim 16, further comprising applying the wound therapy device to the wound in a layered configuration.

18. The method of claim 16, further comprising applying the wound therapy device to the wound in a rolled configuration.

19. The method of claim 16, further comprising applying the wound therapy device to the wound in a loose configuration.

20. The method of claim 16, further comprising applying the wound therapy device to the wound in a folded configuration.